POEM for achalasia
Trial question
Is POEM noninferior to laparoscopic Heller's myotomy in patients with idiopathic achalasia?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
42.0% female
58.0% male
N = 221
221 patients (93 female, 128 male)
Inclusion criteria: patients with symptomatic achalasia
Key exclusion criteria: previous surgery of the stomach or esophagus, including surgical therapy of achalasia, diagnosis of secondary achalasia or other organic causes of dysphagia
Interventions
N=112 POEM (POEM)
N=109 laparoscopic Heller's myotomy (LHM)
Primary outcome
Clinical success at 2 years
83
81.7
83.0 %
62.3 %
41.5 %
20.8 %
0.0 %
Peroral endoscopic
myotomy
Laparoscopic Heller's
myotomy
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in clinical success at 2 years (83% vs. 81.7%; ARD 1.4, 95% CI -8.7 to 11.4)
Secondary outcomes
Borderline significant increase in reflux esophagitis at 3 months (57% vs. 20%; OR 5.74, 95% CI 2.99 to 11)
Safety outcomes
No significant difference in serious adverse events (2.7% vs. 7.3%).
Conclusion
In patients with symptomatic achalasia, POEM was noninferior to laparoscopic Heller's myotomy with respect to clinical success at 2 years.
Reference
Werner YB, Hakanson B, Martinek J et al. Endoscopic or Surgical Myotomy in Patients with Idiopathic Achalasia. N Engl J Med. 2019 Dec 5;381(23):2219-2229.
Open reference URL